| CTRI Number |
CTRI/2020/07/026890 [Registered on: 29/07/2020] Trial Registered Prospectively |
| Last Modified On: |
21/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchakarma Therapies] |
| Study Design |
Other |
|
Public Title of Study
|
Human Trial on Enema and oiling therapy for spine in Low Back Pain (Lumbar Spondylosis) |
|
Scientific Title of Study
|
Clinical Trial on evaluation of regenerative effect of Madhutailika Basti and Ashwagandha Taila Kati Basti in Katigata Vata (Lumbar Spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasant Patil |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya |
| Address |
Professor, PG Dept. of Panchakarma, Ayurveda Mahavidyalaya, Heggeri, HUBLI-24
Dharwad
KARNATAKA
580024
India |
| Phone |
9902749144 |
| Fax |
|
| Email |
ayurvasant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasant Patil |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya |
| Address |
Professor, PG Dept. of Panchakarma, Ayurveda Mahavidyalaya, Heggeri, HUBLI-24
KARNATAKA
580024
India |
| Phone |
9902749144 |
| Fax |
|
| Email |
ayurvasant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasant Patil |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya |
| Address |
Professor, PG Dept. of Panchakarma, Ayurveda Mahavidyalaya, Heggeri, HUBLI-24
KARNATAKA
580024
India |
| Phone |
9902749144 |
| Fax |
|
| Email |
ayurvasant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, Karnataka |
|
|
Primary Sponsor
|
| Name |
RGUHS Bangalore |
| Address |
4th T Block Jayanagar Bangalore 560 041 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Vasant Patil |
Ayurveda Mahavidyalaya |
Heggeri, HUBLI, Dist- Dharwad
Pin-580024
Dharwad
KARNATAKA |
9902749144
ayurvasant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kati Basti
Madhutailika Basti
Gandha Taila |
Intervention-
Drug - Ashwagandha Taila Kati Basti, Madhutailika Basti and Cap Gandha Taila
Dose-
Madhutailika Basti8-
Madhu- 48ml
Saindhava-12 gm.
Taila-48ml
Shatapushpa Kalka-24gm
Erandamoola Kvatha-96ml
Cap Gandha Taila
Dose- 1000mg 2 times after food with lukewarm water.
Duration- Basti and Kati Basti course separately for 8 days in each month and Cap Gandha Taila orally for 2 months.
Procedure of Katibasti:
Using the thick dough a rim will be made and fixed firmly on the low back (lumbo-sacral) region where the highest pain is present. Oil is taken and made warm, poured on the inner wall of rim taking care not to spill out. When oil becomes cool, removed & again refilled with warm oil.
Uniform temperature (41-430 C) and height of oil column 3cm will be maintained throughout the procedure. Time and duration of the procedure varies according to the disease condition. Usually Kaá¹i Basti is done for 30-45 minutes. Oil will be changed at the end of 4th day.9
Procedure of Niruha Basti-
1. Ten minutes local massage over abdomen, thigh, and back will be done followed by fomentation
2. Advise the patient to lie down in the left lateral position on the Basti table, keeping his/her left hand below the head as a pillow, extend the left leg completely and flex the right leg at the knee joint, keeping on the left leg by flexing the hip joint
3. In a Khalva Ynatra, above said ingredients will be added one by one with proper trituration. At last the mixture will be churned.
4. Prepared enema solution will be filled into plastic bag and Basti Netra inserted and tied.
5. Introduce the Bastinetra slowly in the direction of the vertebral column up to ¼ part of the Netra Then press the Putaka gradually and instruct the patient to breath in deeply.
6. Then the patient is asked to lie down in the supine position with a pillow below the hips till he gets the urge for defecation and when he/she gets the urge told to sit in Utkatasana and pass the urge.
7. Observe Yoga, Ayoga and Atiyoga Lakshana
8. After observing the Samyak Niroodha Lakshana the patient is advised to take hot water bath and light diet.
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having clinical features of low back pain worsens on long-standing and sitting stiffness, and restricted movement for more than 1 year with radiological evidence of Lumbar Spondylosis such as disc dehydration, disc narrowing, posterior disc protrusion,anterior disc herniation, disc extrusion (bulge), disc sequestration, and disc migration.
2. 30 to 60 years of age irrespective of sex, religion and race will be selected. |
|
| ExclusionCriteria |
| Details |
1. Patients having severe degeneration of the spine, tumors of the spine, tuberculosis of the spine, and severe spinal injury
2. Patients having neurological deficit due to spinal canal stenosis, spinal malignancy, Cauda equina syndrome, sciatica
3. Patients having systemic inflammatory disorders, fracture
4. Patients having uncontrolled Type 2 DM, Uncontrolled HTN
5. Patients unfit for Niruha Basti
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MRI of LS spine |
baseline and at the end of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome measure – RMDQ, NPRS, Schober’s Test
|
Baseline, 15th, 30th, 45th and and at the end of trial |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
13/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Lumbar spondyloses (LS) is characterized by degenerative changes in the spine, intervertebral disc or facet joints, vertebral body sclerosis, and hypertrophy of spinal column ligaments and others. It will contribute the society with an economical, effective, and safe alternative to conventional medicine and thus avoiding the burden of spine surgeries. Panchakarma therapies are the choice of modalities for the treatment of degenerative disorders especially lumbar spondylosis. Aims and objectives: 1. To evaluate the regenerative effect of Madhutailika Basti and Ashwagandha Taila Kati Basti in Katigata Vata using radiological parameter 2. To evaluate the efficacy of Madhutailika Basti and Ashwagandha Taila Kati Basti in Katigata Vata using Roland Morris Disability Questionnaire (RMDQ) and Numeric Pain Rating Scale (NPRS). Methods and materials: Randomized open-labeled uncontrolled clinical trial using Black Box design. The trial will be carried out on sixty patients of Katigata Vata with Panchakarma Interventions Kati Basti with Ashwagandha Taila, Local massage with Ashwagandha Taila, Madhutailika Basti and Cap Gandha Taila orally for 2 months. Patients will be done baseline and follow-up assessment using MRI and RMDQ, NPRS, Schober’s test. |